Study of Ocular Penetration of Topically Administered Fluoroquinolones

Johns Hopkins University50 enrolled

Overview

This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Cataract Extraction

Interventions

Moxifloxacin 0.5% ophthalmic solutionDRUG

Administer moxifloxacin study drug prior to cataract surgery.

Besifloxacin 0.6% ophthalmic suspensionDRUG

Administer besifloxacin study drug prior to cataract surgery.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who have a visually significant cataract and are planning to have cataract surgery. * Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board. Exclusion Criteria: * Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form. * Subjects who signs of ocular infection or active inflammation in the study eye. * Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome. * Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol. * Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study. * Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating. * Subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.

Locations (1)

The Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Aqueous Humor Concentration of Study Drug

Patients were randomly assigned to receive one drop of either moxifloxacin or besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30 minutes prior to the time of the cataract incision. The aqueous humor was corrected through the paracentesis site. The specimen was transferred immediately to a polypropylene tube and stored upright at ≤ 20° C. Moxifloxacin and besifloxacin concentrations in the aqueous humor were determined using a validated high performance liquid chromatography (HPLC)-tandem mass spectrometry method.

Time frame: approximately 3 to 4 months

Secondary Outcomes

Disk Diffusion Assay of Collected Aqueous Humor

A disk diffusion assay was performed to determine the relative antimicrobial activity of the study drug in the aqueous humor. The reference organism used was a clinical isolate of S. epidermidis that will be grown and adjusted to a 0.5 MacFarland turbidity standard. The standardized suspension was inoculated onto a Mueller-Hinton II agar. A sample of the aqueous humor was applied to 6 mm sterile disks, dried, and then placed onto the inoculated Mueller-Hinton II agar plates. The plates were incubated for 24 hours at 35° C. The zone sizes were then recorded.

Time frame: Approximately 3-4 months.

Data from ClinicalTrials.gov

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